Systemic SclerosisPhase 4NCT03558854
Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients
A Phase 4 study testing Acetylsalicylic acid in people with Systemic Sclerosis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon, precede fibrosis and organic dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Acetylsalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Aug 2018to 26 Oct 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fulfill Systemic sclerosis EULAR/American College of Rheumatology 2013 classification criteria;
- Pharmacological treatment with stable dosages for the last three months.
Who cannot join
- Pregnancy;
- Use of anticoagulants, NSAIDs or antiplatelets drugs;
- Diagnose of other autoimmune rheumatic diseases, coronary diseases, cerebrovascular diseases and severe peripheral artery diseases;
- Active infection;
- Contraindication to acetylsalicylic acid use.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Systemic Sclerosis Outpatient Clinic, Hospital São Paulo
São Paulo, São Paulo
About this study
Official title: Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon, precede fibrosis and organic dysfunction. There is no available treatment that reverses the vascular damage caused by the disease to the moment, although there are several medications recommended for the relief of manifestations due to vascular injury. Acetylsalicylic acid (ASA) is one of the medications that can be used for the treatment of vascular injury present in systemic sclerosis, but still without a fully proven benefit. This study aims to evaluate the effectiveness of ASA on microcirculation alterations in patients with systemic sclerosis by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and laser Doppler imaging. In addition, a blood sample will be collected for dosing the following vascular lesion markers: endothelin-1, von Willebrand factor, thromboxane, and platelet-derived, endothelial-derived and monocyte-derived microparticles.
- Conditions
- Systemic Sclerosis
- Being tested
- Acetylsalicylic acid, Placebo oral capsule
- Keywords
- Systemic sclerosis, Acetylsalicylic acid, Vascular dysfunction
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acidDrug
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
Placebo oral capsuleDrug
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| ASA group | Active comparator | Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks Receives: Drug: Acetylsalicylic acid |
| Placebo oral capsule group | Placebo comparator | Identical pill containing placebo, taken once daily for 04 weeks Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of thromboxane B2
Measured by ELISA
Measured: Baseline and 4 weeks
Secondary outcomes (4)
Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles
Measured by flow cytometry
Measured: Baseline and 4 weeks
Serum level of von Willebrand factor
Measured by ELISA
Measured: Baseline and 4 weeks
Serum level of endothelin-1
Measured by ELISA
Measured: Baseline and 4 weeks
Digital blood flow
Measured by laser Doppler imaging
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start28 Aug 2018
- Primary completion2 Sep 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiane Kayser, Federal University of São Paulo
- Investigators
- Cristiane Kayser, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558854
- Sponsor's protocol ID
- 0246/2018
- Status last verified
- Nov 2021
- First submitted
- 3 May 2018
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Under discussion
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT03558854
- Acronym / sponsor ID
- 0246/2018
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic sclerosis, Acetylsalicylic acid, Vascular dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon, precede fibrosis and organic dysfunction. There is no available treatment that reverses the vascular damage caused by the disease to the moment, although there are several medications recommended for the relief of manifestations due to vascular injury. Acetylsalicylic acid (ASA) is one of the medications that can be used for the treatment of vascular injury present in systemic sclerosis, but still without a fully proven benefit. This study aims to evaluate the effectiveness of ASA on microcirculation alterations in patients with systemic sclerosis by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and laser Doppler imaging. In addition, a blood sample will be collected for dosing the following vascular lesion markers: endothelin-1, von Willebrand factor, thromboxane, and platelet-derived, endothelial-derived and monocyte-derived microparticles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASA group | Active comparator | Drug: Acetylsalicylic acidPill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks |
| Placebo oral capsule group | Placebo comparator | Drug: Placebo oral capsuleIdentical pill containing placebo, taken once daily for 04 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fulfill Systemic sclerosis EULAR/American College of Rheumatology 2013 classification criteria;
- Pharmacological treatment with stable dosages for the last three months.
Key exclusion criteria (5 listed)
- Pregnancy;
- Use of anticoagulants, NSAIDs or antiplatelets drugs;
- Diagnose of other autoimmune rheumatic diseases, coronary diseases, cerebrovascular diseases and severe peripheral artery diseases;
- Active infection;
- Contraindication to acetylsalicylic acid use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acidPatients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks | Drug | ASA group |
| Placebo oral capsulePatients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks | Drug | Placebo oral capsule group |
Primary outcome
Serum level of thromboxane B2
Time frame: Baseline and 4 weeks
Measured by ELISA
4 secondary outcomes
Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles
Time frame: Baseline and 4 weeks
Serum level of von Willebrand factor
Time frame: Baseline and 4 weeks
Serum level of endothelin-1
Time frame: Baseline and 4 weeks
Digital blood flow
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: Undecided. Under discussion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristiane Kayser, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetylsalicylic acid in people with Systemic Sclerosis, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of thromboxane B2 (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.